Azelix understands the importance of proper planning of your product. Based on our experience and seasoned team of regulatory and scientific strategy experts, we are able to help you develop a road map to take you from whatever phase of research you’re in.

With our consultations, we always provide you with our best options and  recommendations to your approach with honesty and transparency. Our regulatory team of experts can provide the following services:

  • Product Development Strategy
  • Study Design & Scientific Advice
  • Submission Strategy
  • Meeting Participation: pre-IND, EOP1, EOP2
  • Application Preparation & Submission
  • IND, NDA, BLA, 505(b)(2), ANDA
  • eCTD Compliance
  • Designated US Agent